FDA WARNING_LETTER - Exer Labs - October 24, 2024

FDA WARNING_LETTER for Exer Labs on October 24, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Exer Labs on October 24, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 360j(g)

21 CFR 820.30(a)

21 CFR 820.25(b)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

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Record Information

Company

Exer Labs

Inspection Date

October 24, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Sean M. Boyd (Office Director)

ID: bd668a0a-0d0f-41e4-92fa-784415ff9f9c

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